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The comparison of efficacy between different doses of palonosetron and ondansetron-dexamethasone for preventing postoperative nausea and vomiting in patients undergoing middle ear surgery: a 3-arm randomized controlled trial

The comparison of efficacy between different doses of palonosetron and ondansetron-dexamethasone for preventing postoperative nausea and vomiting in patients undergoing middle ear surgery: a 3-arm randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260411003
Enrollment
100
Registered
2026-04-11
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients age 18 to 80 years old who scheduled for elective middle ear surgery at King Chulalongkorn Memorial Hospital Postoperative nausea and vomiting, middle ear surgery

Interventions

Palonosetron 1 mcg/kg IV after induction, an equivalent volume of normal saline 30 mins before end surgery ,Dexamethasone 4 mg IV + Palonosetron 0.5 mcg/kg IV after induction, an equivalent volume
Palonosetron alone (Group P),Dexamethasone + Palonosetron (Group DP),Dexamethasone + Normal saline (Group DO)

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 80 years old 2. Undergoing for elective middle ear surgery at King Chulalongkorn Memorial Hospital 3. Patients classified as American Society of Anesthesiologists (ASA) physical status I, II and III

Exclusion criteria

Exclusion criteria: 1. Patients who decline to participate in the study 2. Patients with a history of allergy or contraindication to dexamethasone, ondansetron, palonosetron, or any other drugs used in the study 3. Pregnant patients 4. Patients with chronic opioid use (opioid therapy >3 months) 5. Patients receiving antipsychotic medications 6. Patients who have received prophylactic or therapeutic antiemetic drugs within 24 hours prior to surgery 7. Patients who have received chemotherapy within 4 weeks before surgery 8. Patients who are not extubated after surgery

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery Within 24 hours after surgery Postoperative nausea and vomiting (PONV) score

Secondary

MeasureTime frame
Incidence of postoperative nausea and vomiting (PONV) within 48 hours after surgery Within 48 hours after surgery Postoperative nausea and vomiting(PONV) score,Severity of PONV at postoperative time intervals Within 48 hours after surgery Postoperative nausea and vomiting(PONV) score,Total amount of rescue antiemetic medications administered within 48 hours postoperatively Within 48 hours after surgery Total amount of rescue antiemetic medications,Duration of stay in the post-anesthesia care unit (PACU) - Duration of stay in post-anesthesia care unit (PACU),Incidence of dizziness, headache, sore throat Within 48 hours after surgery VAS score,Patient satisfaction with PONV prophylaxis Within 48 hours after surgery Likert scale

Countries

Thailand

Contacts

Public ContactKullaporn Mingvoramethakul

Chulalongkorn University

mintkllprn@gmail.com0918845151

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026